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Effect of Amino Acids and Sugar Alcohols on Gastric Emptying and Release of Satiation Peptides in Humans

Primary Purpose

Endocrine System Diseases

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
0.52 g L-Tryptophan
1.56 g L-Tryptophan
1.56 g L-Leucine
50 g Xylitol
75 g Erythritol
75 g Glucose
300 mL tap water
50 mg 13C-sodium acetate
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endocrine System Diseases

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy normal weight subjects with a body-mass index of 19.0-24.9
  • Healthy obese subjects with a body-mass index of > 30
  • Normal eating habits (no diets; no dietary changes; no special dietary habits, such as vegetarian/vegan)
  • Age 18-40 years
  • Stable body weight for at least three months

Exclusion Criteria:

  • Smoking
  • Substance abuse
  • Regular intake of medications (except for oral contraceptives)
  • Medical or psychiatric illness
  • History of gastrointestinal disorders
  • Food allergies
  • Pregnancy, breast feeding

Sites / Locations

  • University Hospital Basel, Phase 1 Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

0.52 g L-Tryptophan

1.56 g L-Tryptophan

1.56 g L-Leucine

50 g Xylitol

75 g Erythritol

75 g Glucose

Tap water

Arm Description

0.52 g L-Tryptophan in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube

1.56 g L-Tryptophan in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube

1.56 g L-Leucine in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube

50 g Xylitol in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube

75 g Erythritol in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube

75 g Glucose in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube

300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube

Outcomes

Primary Outcome Measures

Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Plasma concentrations of glucose
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Plasma concentrations of insulin are measured
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Plasma concentrations of glucagon are measured
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Plasma concentrations of glucagon-like Peptide (GLP-1) are measured
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Plasma concentrations of PYY are measured
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Plasma concentrations of cholecystokinin are measured

Secondary Outcome Measures

Effect of different aminoacids and sugar alcohols on gastric emptying
measured by C13 breath test

Full Information

First Posted
May 26, 2015
Last Updated
September 28, 2015
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02563847
Brief Title
Effect of Amino Acids and Sugar Alcohols on Gastric Emptying and Release of Satiation Peptides in Humans
Official Title
Effect of Amino Acids and Sugar Alcohols on Gastric Emptying and Release of Satiation Peptides in Normal Weight and Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
With this study the investigators investigate the effects of amino acids (tryptophan in two different concentrations, leucin) and sugar alcohols (xylitol, erythritol) on satiety mechanisms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocrine System Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.52 g L-Tryptophan
Arm Type
Active Comparator
Arm Description
0.52 g L-Tryptophan in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube
Arm Title
1.56 g L-Tryptophan
Arm Type
Active Comparator
Arm Description
1.56 g L-Tryptophan in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube
Arm Title
1.56 g L-Leucine
Arm Type
Active Comparator
Arm Description
1.56 g L-Leucine in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube
Arm Title
50 g Xylitol
Arm Type
Active Comparator
Arm Description
50 g Xylitol in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube
Arm Title
75 g Erythritol
Arm Type
Active Comparator
Arm Description
75 g Erythritol in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube
Arm Title
75 g Glucose
Arm Type
Placebo Comparator
Arm Description
75 g Glucose in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube
Arm Title
Tap water
Arm Type
Placebo Comparator
Arm Description
300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube
Intervention Type
Dietary Supplement
Intervention Name(s)
0.52 g L-Tryptophan
Intervention Type
Dietary Supplement
Intervention Name(s)
1.56 g L-Tryptophan
Intervention Type
Dietary Supplement
Intervention Name(s)
1.56 g L-Leucine
Intervention Type
Dietary Supplement
Intervention Name(s)
50 g Xylitol
Intervention Type
Dietary Supplement
Intervention Name(s)
75 g Erythritol
Intervention Type
Dietary Supplement
Intervention Name(s)
75 g Glucose
Intervention Type
Dietary Supplement
Intervention Name(s)
300 mL tap water
Intervention Type
Other
Intervention Name(s)
50 mg 13C-sodium acetate
Primary Outcome Measure Information:
Title
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Description
Plasma concentrations of glucose
Time Frame
changes from baseline to three hours after treatment
Title
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Description
Plasma concentrations of insulin are measured
Time Frame
changes from baseline to three hours after treatment
Title
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Description
Plasma concentrations of glucagon are measured
Time Frame
changes from baseline to three hours after treatment
Title
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Description
Plasma concentrations of glucagon-like Peptide (GLP-1) are measured
Time Frame
changes from baseline to three hours after treatment
Title
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Description
Plasma concentrations of PYY are measured
Time Frame
changes from baseline to three hours after treatment
Title
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Description
Plasma concentrations of cholecystokinin are measured
Time Frame
changes from baseline to three hours after treatment
Secondary Outcome Measure Information:
Title
Effect of different aminoacids and sugar alcohols on gastric emptying
Description
measured by C13 breath test
Time Frame
changes from baseline to four hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy normal weight subjects with a body-mass index of 19.0-24.9 Healthy obese subjects with a body-mass index of > 30 Normal eating habits (no diets; no dietary changes; no special dietary habits, such as vegetarian/vegan) Age 18-40 years Stable body weight for at least three months Exclusion Criteria: Smoking Substance abuse Regular intake of medications (except for oral contraceptives) Medical or psychiatric illness History of gastrointestinal disorders Food allergies Pregnancy, breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Beglinger, Prof.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel, Phase 1 Research Unit
City
Basel
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27875537
Citation
Meyer-Gerspach AC, Hafliger S, Meili J, Doody A, Rehfeld JF, Drewe J, Beglinger C, Wolnerhanssen B. Effect of L-Tryptophan and L-Leucine on Gut Hormone Secretion, Appetite Feelings and Gastric Emptying Rates in Lean and Non-Diabetic Obese Participants: A Randomized, Double-Blind, Parallel-Group Trial. PLoS One. 2016 Nov 22;11(11):e0166758. doi: 10.1371/journal.pone.0166758. eCollection 2016.
Results Reference
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Effect of Amino Acids and Sugar Alcohols on Gastric Emptying and Release of Satiation Peptides in Humans

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